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*Terms and Conditions

Iroko Cares™ Savings Program Instructions, Terms, and Conditions: This card is valid for eligible patients with commercial insurance. This card may be used to reduce your out-of-pocket cost for 30 or more capsules of VIVLODEX®, ZORVOLEX®, or TIVORBEX®. Patient must be 18 years of age or older to participate in this program. Not valid where third-party payer (including secondary insurance) covers full cost of prescription without patient liability. Redeem this card only when accompanied by a valid prescription for VIVLODEX®, ZORVOLEX®, or TIVORBEX®.

With this card, commercially-insured patients may pay as little as $10, if product is covered by primary insurance. See Terms and Conditions below.

Patients with questions about using the savings card should call 1-888-591-9796.

Pharmacist Instructions for a Patient with Commercial Insurance: Submit the claim to the primary Third Party Payer first, then submit the balance due to Therapy First Plus as a Secondary Payer COB [coordination of benefits] with patient responsibility amount and a valid Other Coverage Code (e.g. 8). Patient may pay as little as $10 if product is covered by primary insurance. Maximum reimbursement limits apply. Reimbursement will be received from Therapy First Plus.

Valid Other Coverage Code Required. Pharmacists, for any questions regarding Therapy First Plus online processing please call the Help Desk at 1-800-422-5604.

The ‘Swirl Design logo’ and SoluMatrix Technology™ are trademarks of iCeutica Pty Ltd., and are licensed to Iroko.

This offer is valid only in the United States. Program is applicable only for commercially-insured patients. Cash discount cards are not commercial payers and are not eligible to be used for this program. Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan (including Part D), Medigap, VA, DOD or Tricare or other federal or state health programs (such as medical assistance programs). If the patient is eligible for benefits under any such program, the patient cannot use this offer. By using this offer, the patient certifies that he or she will comply with any terms of his or her health insurance contract requiring notification to his or her payer of the existence and/or value of this offer. It is illegal to (or offer to) sell, purchase, or trade this offer. This offer is not transferable. Cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription(s). Not valid if reproduced. Void where prohibited by law. Program managed by PSKW, LLC on behalf of Iroko Pharmaceuticals, LLC. The parties reserve the right to rescind, revoke, amend or terminate this offer without written notice at any time.

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IMPORTANT SAFETY INFORMATION

SEE IMPORTANT NEW SAFETY INFORMATION IN PRODUCT LABELING

Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

TIVORBEX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

TIVORBEX is contraindicated in patients with: a known hypersensitivity to indomethacin or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

TIVORBEX should be used at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

Elevation of one or more liver tests may occur during therapy with NSAIDs. Rare, sometimes fatal, cases of severe hepatic injury have been reported. Physicians should measure transaminases before starting and periodically during long-term treatment with TIVORBEX. TIVORBEX should be discontinued immediately if clinical signs and symptoms of liver disease develop.

NSAIDs, including TIVORBEX, can lead to the new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of CV events. Blood pressure should be monitored during treatment with TIVORBEX. NSAIDs may diminish the antihypertensive activity of loop and thiazide diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers.

NSAID use has been associated with an increase in the risk of MI, hospitalizations due to heart failure, and death. Also, fluid retention and edema have been observed in patients taking NSAIDs. Avoid the use of TIVORBEX in patients with severe heart failure.

Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. TIVORBEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, dehydration, hypovolemia, and those taking diuretics, ACE inhibitors, or ARBs. Avoid the use of TIVORBEX in patients with advanced renal disease. Increases in serum potassium levels, including hyperkalemia, have been reported with NSAID use.

Anaphylactic reactions may occur in patients with the aspirin triad or in patients without prior exposure to TIVORBEX. TIVORBEX should be discontinued immediately if an anaphylactic reaction occurs.

NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens - Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. TIVORBEX should be discontinued if rash or other signs of local skin reaction occur.

Indomethacin may aggravate depression, and other psychiatric disturbances, epilepsy, or parkinsonism, and should be used with caution in patients with these conditions. Indomethacin may cause drowsiness; therefore patients should be cautioned about engaging in activities requiring mental alertness and motor coordination. Discontinue TIVORBEX if severe central nervous system (CNS) adverse reactions develop.

Corneal deposits and retinal disturbances have been observed after prolonged therapy with indomethacin. Periodic ophthalmologic examinations are advisable in patients receiving prolonged therapy. TIVORBEX is not indicated for long-term treatment.

Starting at 30 weeks of gestation, NSAIDs, including TIVORBEX, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur.

Concomitant administration of anticoagulants, antiplatelet agents (e.g., aspirin), SSRIs, SNRIs, salicylates, or other NSAIDs with TIVORBEX may increase the risk of bleeding.

The anti-inflammatory and anti-pyretic activity of TIVORBEX may mask the signs of infection.

Since serious GI, hepatic, and renal events have been reported with NSAID use, consider monitoring CBC and chemistry profile in patients on long-term NSAID therapy.

TIVORBEX capsules do not result in an equivalent systemic exposure to other formulations of oral indomethacin. Therefore, do not substitute similar dose strengths of other indomethacin products for TIVORBEX.

Indication

TIVORBEX is a nonsteroidal anti-inflammatory drug (NSAID) indicated for treatment of mild to moderate acute pain in adults.

Please see full Prescribing Information or additional important safety and dosing information for TIVORBEX.